At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Colorectal Cancer Screening in Average-risk Population: a Multicenter, Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy.
In Brief
A clinical study evaluating Immunochemical fecal occult blood test and Colonoscopy for Colorectal Cancer and Colorectal Neoplasm. Completed, enrolled 55,498 participants across 8 sites.
Detailed Summary
Aims: 1. To compare the efficacy of biennial immunochemical fecal occult blood test (iFOBT) versus colonoscopy every 10 years for the reduction of colorectal cancer-related mortality at 10 years in average-risk population. 2. To determine the compliance and complications associated with both strategies. Methods: Multicenter, randomized, controlled study in 8 Spanish regions (Aragón, Canarias, Catalunya, Euskadi, Galicia, Madrid, Murcia and Valencia). Study groups: * Group I: iFOBT (OC Sensor®) in one stool sample, followed by colonoscopy when a positive result. * Group II: colonoscopy. Sample-size calculation: 27,749 subjects in each study group (total: 55,498).
Study Details
Timeline
Interventions
Biennial, without diet restriction, 1 stool sample. Positive cut-off level: 75 ng/ml.
Every 10 years, with sedation.